Provisional Consent to the Distribution of a New Medicine
Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and set out in the Schedule hereto:
| Product: | Jemperli |
| Active Ingredient: | Dostarlimab 50mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturer: | Ajinomoto Althea Inc, California, United States of America |
|
Provisional consent is granted until 6 July 2025. This consent is given subject to the following conditions: The New Zealand Sponsor must fulfil the following obligations within the timeline specified, the date of which may be altered by mutual agreement with Medsafe:
|
|
Dated this 20th day of May 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).